New Framework Agreement on the Supply and Pricing of Medicines Announced

Following the commencement of talks in September 2025, the Minister for Health has recently announced the conclusion of two new Framework Agreements in principle. Our Life Sciences Regulatory team outlines this update for Ireland’s pharmaceutical sector.

What you need to know

• The Irish Pharmaceutical Healthcare Association (IPHA) Framework Agreement between the HSE and IPHA outlines the pricing, supply and reimbursement procedures for medicines on the HSE Reimbursement List.
• The Medicines for Ireland (MFI) Framework Agreement between the HSE and the MFI aims to strengthen the security of medicine supply and reduce the risk of shortages for patients.
• New Framework Agreements in principle were announced on 20 January 2026.
• The Agreements will begin to apply once their final text is agreed, and will remain in force until 31 December 2029.

The Minister for Health Jennifer Carroll MacNeill TD recently announced the successful negotiation of two new Framework Agreements in principle by the HSE with:

• The Irish Pharmaceutical Healthcare Association, and
• Medicines for Ireland

These Agreements contain a range of measures designed, among other things, to:

• Deliver faster patient access to medicines
• Strengthen the security of medicine supply and reduce the risk of shortages for patients
• Encourage off-patent launches to streamline access to medicines, and
• Support financial sustainability

These Agreements replace the previous versions introduced in 2021, and will apply until 31 December 2029.

IPHA Framework Agreement

A key feature of the new IPHA Framework Agreement is a policy commitment to meet the statutory 180-day timeline for decisions on the reimbursement of new medicines. Under the Health (Pricing and Supply of Medical Goods) Act 2013 (as amended), the HSE is obliged to make decisions on applications for reimbursement within 180 days. However, according to a position paper published by the IPHA in 2025, 86% of medicines reimbursed between 2022 and 2024 exceeded this timeline. To support this objective, the Agreement enhances the capacity of the HSE Drugs Group to improve application processing.

Other notable features of the IPHA Framework Agreement in principle include:

• Measures to implement more predictable pricing structures and lifecycle management of medicines
• Mechanisms to manage financial risk, and
• Structures to enhance engagement between the State and the pharmaceutical representative body throughout the life of the Agreement

The Framework Agreement establishes a joint oversight committee to monitor the delivery of commitments, including timelines for reimbursement, access to new medicines and financial sustainability measures.

MFI Framework Agreement

The Agreement in principle reached with the MFI focuses on ensuring the supply of essential medicines and reducing the risk of medicine shortages.

This Framework Agreement provides, among other things, for the following measures:

• Tiered-pricing mechanisms to encourage companies to launch generic and biosimilar products onto the Irish market as soon as possible following the expiry of a patent
• Review and adaptation of the Best-Value Biologics process to ensure that best-value medicines are introduced onto the market as early as possible
• To enhance security of supply and reduce the use of high-cost Exempt Medicinal Products, MFI companies will be encouraged to apply for licensing and reimbursement in Ireland

Next steps

The text of the new Framework Agreements is expected to be finalised over the course of the next month. Following this, the finalised Framework Agreements will be published shortly after and will begin to take effect.

For more information and expert advice, contact our Life Sciences Regulatory team.

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The content of this article is provided for information purposes only and does not constitute legal or other advice.